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Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
This study is ongoing, but not recruiting participants.
Study NCT00285675   Information provided by Novacea
First Received: January 31, 2006   Last Updated: May 30, 2006   History of Changes

January 31, 2006
May 30, 2006
April 2006
 
 
 
Complete list of historical versions of study NCT00285675 on ClinicalTrials.gov Archive Site
 
 
 
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.

This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
  • Androgen Independent Prostate Cancer (AIPC)
  • Non Small Cell Lung Cancer (NSCLC)
Drug: DN-101 (calcitriol) - Drug
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
January 2008
 

Inclusion Criteria:

  • Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
  • Prior investigational therapy other than DN-101 within 30 days of enrollment
  • Known hypersensitivity to calcitriol
  • Pregnancy (women of childbearing potential only)
  • Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00285675
 
011-016
Novacea
None
 
Novacea
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP